UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031530
Receipt number R000035842
Scientific Title A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Date of disclosure of the study information 2018/03/01
Last modified on 2023/03/05 20:57:06

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Basic information

Public title

A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System

Acronym

A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System

Scientific Title

A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System

Scientific Title:Acronym

A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System

Region

Japan


Condition

Condition

Uterine fibroids
Uterine adenomyosis
Uterine prolapse
Otherwise benign uterine disease

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of robotic assisted hysterecomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total operating time

Key secondary outcomes

Console time
Amount of bleeding during the operation
Intraoperative complications
Postoperative complications
Hospital days


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Robotic assisted hysterectomy performed with da Vinci surgical system

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Female

Key inclusion criteria

1) Patients who have benign uterine disease for which hysterectomy is indicated.
2) Patient's BMI is lower than 35.
3) Patient's function of major organs (bone marrow, heart, lung, liver and kidneys) is good and suitable for the operation.
4) Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement.

Key exclusion criteria

1) Patients who have experienced more than three times of laparotomy.
2) Patients who have severe endometriosis.
3) Patients who have the uterus more than 15cm in diameter.
4) Patients who have mental disease or mental symptoms, difficult to participate to the study.
5) Patients who have brain aneurysm or glaucoma.
6) Patients who are judged ineligible by the principal investigator or sub-investigators.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Nishii

Organization

University Hospital, Mizonokuchi, Teikyo University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

213-0002

Address

5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa

TEL

044-844-3333

Email

nishii@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Tsuchiya

Organization

University Hospital, Mizonokuchi, Teikyo University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

213-0002

Address

5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa

TEL

044-844-3333

Homepage URL


Email

tsuchiya@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Teikyo University

Address

2-11-1 Kaga Itabashi-ku Tokyo Japan

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 02 Month 22 Day

Date of IRB

2018 Year 02 Month 22 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2023 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2023 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035842


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name